BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM 90-S SERFAS ENERGY SUCTION PROBE

    MDR report key: 2132303 · Received June 13, 2011

    Report

    Report Number
    2648666-2011-00149
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE TIP OF THE DEVICE WAS CRACKED. IT WAS FURTHER REPORTED THAT THE SURGEON COULD NOT FIND THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM 90-S SERFAS ENERGY SUCTION PROBE SERFAS ENERGY SUCTION PROBE GEI STRYKER ENDOSCOPY PUERTO RICO 10298AE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK